Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

NCT ID: NCT01979926

Last Updated: 2014-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.

Detailed Description

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Conditions

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Acute Exacerbation of Chronic Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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N02RS1 200mg

Combination of Broussonetia spp and Lonicera spp

Group Type EXPERIMENTAL

Combination of Broussonetia spp and Lonicera spp

Intervention Type DRUG

600 mg/ day or 1200 mg/ day for 7 days

N02RS1 400mg

Combination of Broussonetia spp and Lonicera spp

Group Type EXPERIMENTAL

Combination of Broussonetia spp and Lonicera spp

Intervention Type DRUG

600 mg/ day or 1200 mg/ day for 7 days

Placebo

Sugar pill

Group Type PLACEBO_COMPARATOR

Combination of Broussonetia spp and Lonicera spp

Intervention Type DRUG

600 mg/ day or 1200 mg/ day for 7 days

Interventions

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Combination of Broussonetia spp and Lonicera spp

600 mg/ day or 1200 mg/ day for 7 days

Intervention Type DRUG

Other Intervention Names

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N02RS1

Eligibility Criteria

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Inclusion Criteria

* Patients over 18, under 75 years of age
* Patients Acute and Chronic Bronchitis

Exclusion Criteria

* Patients who have gotten a glucocorticoids treatment within 4 weeks.
* Patients who need treatments of antibiotic and acute bronchitis infection.
* Patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days.
* Bronchial asthma patient.
* Patients who have an indication of bleeding.
* Patients who have a serious heart and renal disease or liver ailment or immunosuppressive response.
* Patients who have history of over 3 phage of Chronic obstructiv lung disease
* Bronchiectasis patients.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PharmaKing

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wayne B An, Bs

Role: STUDY_DIRECTOR

Korea Pharmaceutical Manufacturers Association

Locations

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Seoul Nat'l University of Boramae Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PMK-N02RS1

Identifier Type: -

Identifier Source: org_study_id